Usual Adult Dose for Leishmaniasis

Weight 30 to 44 kg: 50 mg orally twice a day
Weight at least 45 kg: 50 mg orally 3 times a day
Duration of therapy: 28 consecutive days

Uses: For the treatment of:

• Visceral leishmaniasis due to Leishmania donovani
• Cutaneous leishmaniasis due to L braziliensis, L guyanensis, and L panamensis
• Mucosal leishmaniasis due to L braziliensis

Usual Pediatric Dose for Leishmaniasis

12 years or older:

• Weight 30 to 44 kg: 50 mg orally twice a day
• Weight at least 45 kg: 50 mg orally 3 times a day

• Visceral leishmaniasis due to L donovani
• Cutaneous leishmaniasis due to L braziliensis, L guyanensis, and L panamensis
• Mucosal leishmaniasis due to L braziliensis

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• EMBRYOFETAL TOXICITY: This drug is contraindicated in pregnancy; based on animal data, it may cause fetal harm. Pregnancy status should be verified in patients of childbearing potential before starting this drug. To prevent pregnancy, patients of childbearing potential should use effective contraception during therapy and for 5 months after the last dose.

• Pregnancy
• Sjogren-Larsson-Syndrome
• Hypersensitivity to the active component or any of the ingredients

Dialysis

Data not available

Other Comments

Administration advice:

• Verify pregnancy status before starting this drug in patients of childbearing potential.
• Administer with food to diminish gastrointestinal side effects.
• Administer twice-daily regimen with breakfast and dinner; administer thrice-daily regimen with breakfast, lunch, and dinner.
• Swallow capsule whole; do not break, crush, dissolve, or chew.

• Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
• Protect from moisture.
• Dispense only in original carton.

• Limitations of Use:
• Leishmania species studied in trials evaluating this drug were based on epidemiologic data.
• There may be geographic variation in clinical response of the same Leishmania species to this drug.
• Efficacy has not been evaluated in the treatment of other Leishmania species.

• General: For pregnancy (before starting therapy)
• Hematologic: Platelet count (during therapy for visceral leishmaniasis)
• Hepatic: Liver transaminases (ALT, AST) and bilirubin (during therapy)
• Renal: Renal function, including serum creatinine (weekly during therapy and for 4 weeks after last dose)

• Read the US FDA-approved patient labeling (Medication Guide).
• Complete the entire course of therapy.
• Notify health care provider if gastrointestinal side effects (abdominal pain, nausea, vomiting, diarrhea) are severe or persistent.
• Drink plenty of fluids to avoid dehydration (and, thus, the risk of kidney injury).
• Patients of childbearing potential: Notify health care provider of known/suspected pregnancy; if you become pregnancy during therapy, stop this drug and seek counseling from health care provider.
• Patients of childbearing potential: Use effective contraception during therapy and for 5 months after the last dose; if you use oral contraceptives and vomiting and/or diarrhea occurs, use an additional non-oral method of effective contraception during therapy.
• Male patients: Inform health care provider of any concerning genitourinary symptoms.